Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis

Angioplasty, Balloon Clinical Trial

— INTACT  

Official title:

Economic Evaluation Comparing Standard Balloon Angioplasty Versus Drug-eluted Balloon or Laser-Excimer in Association With Drug-eluted Balloon in the Treatment of Femoropopliteal Artery In-stent Restenosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02599389
• Other study ID #: CHUBX 2014/40
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: May 2020

Study information

• Verified date: November 2019
• Source: University Hospital, Bordeaux
• Contact: Eric DUCASSE, MD, PhD
• Phone: +335 56 79 55 25
• Email: eric.ducasse[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this multicenter triple-arm randomized study is to compare two innovative techniques with the gold standard currently used and providing unsatisfactory results for the In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares the use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with the Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole fibrous material to the standard angioplasty using plain balloons. INTACT study main objective is to assess cost-effectiveness ratio of the treatment of femoropopliteal artery in-stent restenosis by comparing these two innovative strategies and the standard one in terms of cost per Qaly (Quality adjusted life-years) gained at 18 months from a collective perspective.

Description:

The publication show that there is probably an effectiveness gradient (expressed as a proportion of patients with in-stent restenosis a 18 months after the intervention of the first stenosis reduction): standard balloons would be less effective than active balloons themselves less effective than in combination with the excimer laser. Reducing the risk of In-Stent Restenosis has major implications for the treatment of patients because it reduces the use of arterial bypass or amputation, if unable to perform revascularization.

Based on these promising results of efficiency, we can hypothesize that the active balloons in combination with the Excimer laser would improve the quality of life of patients while reducing the cost of their treatment, this compared to only assets balloons. This same improvement in quality of life with reduced costs of care would be observed for only assets compared to standard balloons. In health economic terms, it is therefore likely that the strategy combining assets balloons and Excimer laser is dominant over assets balloons themselves dominant over standard balloons.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient of age > 18 years

• Patient with previously peripheral implanted stent(s) located in or extending to the popliteal artery

• Patient who received this stent between 3-36 months before inclusion

• Patient with one or more in-stent restenosis lesion(s) > 70% in the same arterial segment in association with clinical symptoms of claudication or an critical limb ischemia with Rutherford classification of 2, 3, 4 or 5

• Reference vessel diameter between 4 and 7 mm

• Patient affiliated to a social security regimen

• EC-approved consent form signed by the participant and the investigator (must be signed prior initiation of any study related intervention)

Exclusion Criteria:

• Life expectancy >18 months

• Patient already included in this study (recruitment of the contralateral leg is not allowed)

• Patient contraindicated for the use of antiplatelet therapy

• Pregnant or breast-feeding women

• Patient with a target limb infection being treated

• Patient with a procoagulant blood disease

• Patient with history of contrast agents allergies

• Patient with intolerance to paclitaxel

• Patient with severe renal impairment (GFR <30 ml / min / 1.73 m²) or patient with a creatinine clearance <15 ml / min

• External compression of previously implanted stent

• Patient participating in any clinical trial using another investigational drug or product which could interfere with the interpretation of the trial results.

• Patient under trusteeship or guardianship

Angiographic exclusion criteria :

• Inflow (above) severe lesion >70% or occlusion untreated satisfactorily (residual lesion> 50%) before the management of the target lesion

• Perforation, dissection or lesions on the arterial network access requiring an assumption prior to randomization

• Stent fracture grade 4 or 5 at the target lesion

Related Conditions & MeSH terms

• Angioplasty, Balloon

Intervention

Device:
• Drug-coated balloons

• Excimer Laser

Locations

Country	Name	City	State
France	Clinique Rhône Durance	Avignon
France	Centre Hospitalier Universitaire de Besançon	Besançon
France	University Hospital of Bordeaux - Hospital Pellegrin	Bordeaux
France	Centre Hospitalier Universitaire de Clermont-Ferrand	Clermont-Ferrand
France	Centre Hospitalier Universitaire de Dijon	Dijon
France	Hospices Civils de Lyon	Lyon
France	Hôpital Timone Adultes	Marseille
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Polyclinique Les Fleurs	Ollioules
France	Hôpital Européen Georges Pompidou - AP-HP de Paris	Paris
France	Centre Hospitalier Universitaire de Rennes	Rennes
France	Clinique de L'Europe	Rouen
France	Centre Hospitalier Universitaire de St Etienne	St Etienne
France	Centre Hospitalier Universitaire de Strasbourg	Strasbourg
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental cost per Qaly gained at 18 months		18 months after angioplasty
Primary	Incremental cost per avoided stenosis relapse at 18 months		18 months after angioplasty
Secondary	New In-stent restenosis during follow-up	No recurrence of in-stent restenosis > 50% during follow-up with doppler . The three treatment groups are compared.	1 month, 6 months, 12 months and 18 months after angioplasty
Secondary	A major adverse event	Absence of major event during follow-up as death, lower limb amputation or lack of required revascularization.	1 month, 6 months, 12 months and 18 months after angioplasty
Secondary	Improvement in the walking procedure	Improvement in the walking procedure performing by Strandness test	Before and 12 months after angioplasty
Secondary	Clinical improvement	Clinical improvement by the Rutherford classification at 6, 12 and 18 months. This improvement is objectified by a decrease in category 1 or several classes.	6 months, 12 months and 18 months after angioplasty
Secondary	Systolic blood pressure Index	Index :ratio of brachial pressure and compressible leg artery pressure	6 months, 12 months and 18 months after angioplasty
Secondary	new treatment for the treated lesion		6 months, 12 months and 18 months after angioplasty
Secondary	revascularization, with restenosis of the treated lesion		6 months, 12 months and 18 months after angioplasty
Secondary	recurrence of clinical symptoms		6 months, 12 months and 18 months after angioplasty
Secondary	Blood ultrasonic doppler velocimetry		6 months, 12 months and 18 months after angioplasty